BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12 MM TROCAR

    MDR report key: 10605915 · Received September 29, 2020

    Report

    Report Number
    MW5096952
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    August 31, 2020
    Report Date
    September 25, 2020
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    GCP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING ROBOTIC CASE, THE PLASTIC PIECE OF THE TROCAR FELL OFF BEFORE REACHING THE PATIENT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065756 12 MM TROCAR ENDOSCOPE AND ACCESSORIES GCP APPLIED MEDICAL RESOURCES CORP. 1384276

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention